Commission Regulation (EC) No 1800/2004 of 15 October 2004 concerning the authorisation for 10 years of the additive Cycostat 66G in feedingstuffs, belonging to the group of coccidiostats and other medicinal substancesText with EEA relevance
Modified by
  • Commission Regulation (EC) No 101/2009of 3 February 2009amending Regulation (EC) No 1800/2004 as regards the terms of the authorisation of the feed additive Cycostat 66G(Text with EEA relevance), 32009R0101, February 4, 2009
  • Commission Regulation (EC) No 214/2009of 18 March 2009amending Regulation (EC) No 1800/2004 as regards the terms of the authorisation of the feed additive Cycostat 66G(Text with EEA relevance), 32009R0214, March 19, 2009
  • Commission Implementing Regulation (EU) No 532/2011of 31 May 2011concerning the authorisation of robenidine hydrochloride as a feed additive for rabbits for breeding and rabbits for fattening (holder of authorisation Alpharma Belgium BVBA) and amending Regulations (EC) No 2430/1999 and (EC) No 1800/2004(Text with EEA relevance)Commission Implementing Regulation (EU) No 118/2012of 10 February 2012amending Regulations (EC) No 2380/2001, (EC) No 1289/2004, (EC) No 1455/2004, (EC) No 1800/2004, (EC) No 600/2005, (EU) No 874/2010, Implementing Regulations (EU) No 388/2011, (EU) No 532/2011 and (EU) No 900/2011 as regards the name of the holder of the authorisation of certain additives in animal feed and correcting Implementing Regulation (EU) No 532/2011(Text with EEA relevance), 32011R053232012R0118, June 1, 2011
  • Commission Implementing Regulation (EU) No 118/2012of 10 February 2012amending Regulations (EC) No 2380/2001, (EC) No 1289/2004, (EC) No 1455/2004, (EC) No 1800/2004, (EC) No 600/2005, (EU) No 874/2010, Implementing Regulations (EU) No 388/2011, (EU) No 532/2011 and (EU) No 900/2011 as regards the name of the holder of the authorisation of certain additives in animal feed and correcting Implementing Regulation (EU) No 532/2011(Text with EEA relevance), 32012R0118, February 11, 2012
  • Commission Implementing Regulation (EU) No 118/2012of 10 February 2012amending Regulations (EC) No 2380/2001, (EC) No 1289/2004, (EC) No 1455/2004, (EC) No 1800/2004, (EC) No 600/2005, (EU) No 874/2010, Implementing Regulations (EU) No 388/2011, (EU) No 532/2011 and (EU) No 900/2011 as regards the name of the holder of the authorisation of certain additives in animal feed and correcting Implementing Regulation (EU) No 532/2011(Text with EEA relevance), 32012R0118, February 11, 2012
  • Commission Implementing Regulation (EU) No 1014/2013of 22 October 2013amending Regulations (EC) No 2380/2001, (EC) No 1289/2004, (EC) No 1455/2004, (EC) No 1800/2004, (EC) No 600/2005, (EU) No 874/2010, Implementing Regulations (EU) No 388/2011, (EU) No 532/2011 and (EU) No 900/2011 as regards the name of the holder of the authorisation of certain additives in animal feed(Text with EEA relevance), 32013R1014, October 23, 2013
  • Commission Implementing Regulation (EU) 2020/148of 3 February 2020concerning the authorisation of robenidine hydrochloride (Robenz 66G) as a feed additive for chickens for fattening and amending Regulation (EC) No 1800/2004 (holder of authorisation Zoetis SA)(Text with EEA relevance), 32020R0148, February 5, 2020
Commission Regulation (EC) No 1800/2004of 15 October 2004concerning the authorisation for 10 years of the additive Cycostat 66G in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance)
Article 1In chapter I of Annex B to Directive 70/524/EEC the additive robenidine, belonging to the group "Coccidiostats and other medical substances", shall be deleted.
Article 2The additive Cycostat 66G belonging to the group "Coccidiostats and other medical substances" as set out in the Annex to the present Regulation is authorised for use in animal nutrition under the conditions laid down in that Annex.
Article 3A period of six months from the date of entry into force of this Regulation is permitted to use up the existing stocks of robenidine.
Article 4This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX
Coccidiostats and other medicinal substances
Registration number of the additiveName and the registration number of the person responsible for putting additive into circulationAdditive(Trade name)Composition, chemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationMaximum residue limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff
E 758Zoetis Belgium SARobenidine hydrochloride 66 g/kg(Robenz 66 G)Additive compositionRobenidine hydrochloride: 66 g/kgLignosulfonate: 40 g/kgCalcium sulphate dihydrate: 894 g/kgActive substanceRobenidine hydrochloride,C15H13Cl2N5. HCl,1,3-bis [(p-chlorobenzylidene) amino]-guanidine hydrochloride CAS number: 25875-50-7,Related impurities:N,N',N''-Tris[(p-Cl-benzylidene)amino]guanidine (TRIS): ≤ 0,5 %Bis-4[4-Cl-benzylidene]hydrazine (AZIN): ≤ 0,5 %Chickens for fattening—3036Use is prohibited at least 5 days before slaughter.29 October 2014800 μg robenidine hydrochloride/kg of wet liver.350 μg robenidine hydrochloride/kg of wet kidney.200 μg robenidine hydrochloride/kg of wet muscle.1300 μg robenidine hydrochloride/kg of wet skin/fat.
Turkeys3036Use is prohibited at least 5 days before slaughter.29 October 2014400 μg robenidine hydrochloride/kg of skin/fat.400 μg robenidine hydrochloride/kg of wet liver.200 μg robenidine hydrochloride/kg of wet kidney.200 μg robenidine hydrochloride/kg of wet muscle.
Article 1In chapter I of Annex B to Directive 70/524/EEC the additive robenidine, belonging to the group "Coccidiostats and other medical substances", shall be deleted.
Article 2The additive Cycostat 66G belonging to the group "Coccidiostats and other medical substances" as set out in the Annex to the present Regulation is authorised for use in animal nutrition under the conditions laid down in that Annex.
Article 3A period of six months from the date of entry into force of this Regulation is permitted to use up the existing stocks of robenidine.
Article 4This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX
Coccidiostats and other medicinal substances
Registration number of the additiveName and the registration number of the person responsible for putting additive into circulationAdditive(Trade name)Composition, chemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationMaximum residue limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff
E 758Zoetis Belgium SARobenidine hydrochloride 66 g/kg(Robenz 66 G)Additive compositionRobenidine hydrochloride: 66 g/kgLignosulfonate: 40 g/kgCalcium sulphate dihydrate: 894 g/kgActive substanceRobenidine hydrochloride,C15H13Cl2N5. HCl,1,3-bis [(p-chlorobenzylidene) amino]-guanidine hydrochloride CAS number: 25875-50-7,Related impurities:N,N',N''-Tris[(p-Cl-benzylidene)amino]guanidine (TRIS): ≤ 0,5 %Bis-4[4-Cl-benzylidene]hydrazine (AZIN): ≤ 0,5 %Chickens for fattening—3036Use is prohibited at least 5 days before slaughter.29 October 2014800 μg robenidine hydrochloride/kg of wet liver.350 μg robenidine hydrochloride/kg of wet kidney.200 μg robenidine hydrochloride/kg of wet muscle.1300 μg robenidine hydrochloride/kg of wet skin/fat.
Turkeys3036Use is prohibited at least 5 days before slaughter.29 October 2014400 μg robenidine hydrochloride/kg of skin/fat.400 μg robenidine hydrochloride/kg of wet liver.200 μg robenidine hydrochloride/kg of wet kidney.200 μg robenidine hydrochloride/kg of wet muscle.